This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.

“With food supplements, we have an extremely cost effective and very safe tool to better public health.”
S. Hasslberger - newmediaexplorer.org/sepp/index.htm

Notice: Due to the continuing decline of the Dollar and increased costs, The Vitamin Lawyer Consultancy hourly rate has increased.

To get on to the Global Health Freedom eblast list, please go to: http://www.globalhealthfreedom.org
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2. EU – taking over world food regulations?

Sepp Hasslberger’s Health Supreme Blog often has a very good knowledge of pending issues. He explores the claim that EU “Napoleonic Code” regulation of foods – including natural remedies, dietary supplements and functional foods – is being spearheaded by the European Union. The most serious problem from the viewpoint of the American wellness marketplace is the old legal distinction between “Code” countries, where whatever is not approved is prohibited, and Common Law countries, like the US, where whatever is not forbidden is allowed; the centuries-old struggle between free markets and mercantilism continues!

Sepp quotes one unnamed source: “One American official says flatly that the EU is ‘winning’ the regulatory race, adding: ‘And there is a sense that that is their precise intent.’ He cites a speech by the trade commissioner, Peter Mandelson, claiming that the export of ‘our rules and standards around the world’ was one source of European power. Noting that EU regulations are often written with the help of European incumbents, the official also claims that precaution can cloak ‘plain old-fashioned protectionism in disguise’.”

“Protectionism” is certainly not a friend of advanced healthcare and wellness companies, especially in our globalized world marketplace. Sepp’s article, on the dangers of “HARMonization” with Codex is a must read.

And what would be the effect of the EU takeover on your business? On your vitamin use? Here is what one UK nongovernmental organization, ANH, noted in a report critical of the “science” behind upper limits: “upper levels being considered for nutrients such as beta-carotene could be exceeded by eating two carrots…”

From The Integrator Blog: Parallel Play or a Potent Alliance? Alternative Medicine Practitioners and the Natural Products Industry are Stronger Together - David Matteson, MPM, MURP, MS

"The Natural Products Industry (NPI) and the complementary and alternative medicine (CAM) industry are each in the midst of a major transformation. Their ability to learn how to 'play' together may be crucial to how well these industries grow and succeed over the next few years.

"There is a natural relationship between these two industries. Many policy makers and many consumers see them as flip sides of the same coin. Yet, these two industries have not really acknowledged their interconnectedness, let alone taken active steps to collaborate on their common political and market interests.”

”A broad-ranging survey on health reform topics by the Gilmore Research Group found that 68% of voters believe basic health care benefits should include coverage for any licensed health care professionals.
Licensed professionals directly noted in the survey of 601 Iowa voters were ‘naturopathic physicians, acupuncturists and chiropractors.’ The survey was commissioned by Code Blue Now! - a national, non-partisan, not-for-profit citizen organization formed to build public consensus in health care policy. The Iowa population was strategically selected to have a maximum influence on the healthcare reform debate.”

The FDA’s new Good Manufacturing Practices will be phased in over two years, giving smaller companies some time to get ready… the most difficult area as been the new requirement for “100% Identity Testing” with many companies complaining that there may be no available lab tests that can determine identity where a product has a dozen or more ingredients, some in such low amount as to be nearly nano dilutions.

“The FDA (US Food & Drug Administration) published the final rule on Good Manufacturing Practices, known as GMPs, in June. The soon-to-be-implemented GMP legislation forms part of the 1994 Dietary Supplements Health and Education Act (DSHEA) and is set to provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. Both the Natural Products Association (NPA) and the American Herbal Products Association (AHPA) find fault with the fact that under the current GMPs, only supplement manufacturers, but not ingredient suppliers, can submit petitions for exemptions from 100 percent identity testing.”

It is expected that FDA will accommodate the needs of companies with specialized products that may not be susceptible to the required lab testing.

Vitamin D and Longevity - “Published in the September 10 issue of Archives of Internal Medicine, the meta-analysis examined 18 previously published studies which had suggested that deficiencies in vitamin D lead to a higher risk of death from cancer, heart disease and diabetes. However - given that these illnesses account for between 60 and 70 percent of deaths in high-income nations - the current analysis indicates the opposite. In fact, those individuals isolated from the studies who did take vitamin D had a seven percent lower risk of death than those who did not take it. "If the associations made between vitamin D and these conditions were consistent, then interventions effectively strengthening vitamin D status should result in reduced total mortality," wrote the researchers, hailing from the International Agency for Research on Cancer in France and from the European Institute of Oncology in Italy - nutraingredients-usa.com/news/ng.asp?id=79675
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“In another move to prevent dietary supplements infringing on the territory of pharmaceuticals, the US Food & Drug Administration (FDA) has issued a warning to Zeo Health for three of its products…

“Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Instead, only ingredients not marketed in the US before October 1994 must be approved by FDA before being used in consumer products…

“Unlike, pharmaceutical drugs, dietary supplements are permitted few health claims… "The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease," wrote FDA in a letter to the New York state-based company… FDA objects to …promotion …for cancer prevention and treatment. The agency highlights an example of phrasing to this effect as found on the company's website:

"The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size." The insinuation that the supplement can prevent or treat cancer continues in the dosage information provided by Zeo Health.

"For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily." [VL Notes: these directions are clearly “treatment” directions.]

“FDA also revealed that Zeo Health claims on its website that the supplement Esdifan is recommended for consumers with irritable bowel syndrome and Crohn's disease. "Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market....," stated Zeo Health on its company website, according to FDA.

“The company claims that its Zeolite supplement absorbs toxins associated with alcohol before they make it into the organs: "ZEO absorbs the toxins from the alcohol before they are processed into your organs."

“FDA has urged Zeo Health to respond to its letter within 15 working days of receipt, advising the agency of the steps the company is taking to correct the violations. "Failure to do so may result in enforcement action without further notice." - nutraingredients-usa.com/news/ng.asp?n=78382-zeo-health-fda-warning-letter”
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3. FDA AER draft Guidance finally issued! Excerpts from the guidance:

“1. When do the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act become effective? -- The effective date for compliance with the requirements of this law is December 22, 2007.

2. What types of foods are covered by the Dietary Supplement and Nonprescription Drug Consumer Protection Act requirements? -- The requirements of this law only apply to dietary supplements. No other types of food are covered.

5. What is an "adverse event?" -- An "adverse event" is "any health-related event associated with the use of a dietary supplement that is adverse."

6. What is a "serious adverse event?" -- A "serious adverse event" is an adverse event that: Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

7. What is a "serious adverse event report?" -- A "serious adverse event report" is a report that must be submitted to FDA on MedWatch Form 3500A when a manufacturer, packer, or distributor of a dietary supplement receives any report of a serious adverse event associated with the use of the dietary supplement in the United States.”

The AER Consultants web site, www.aer-consultants.com will be analyzing form 3500A and will be providing assistance for companies to comply.

Factoids: “Food and ingredient prices are growing at a faster pace in China than anywhere else in the world”

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2. Contracting with your web designer

I've seen so many clients have awful problems with web designers!

Here's the issue from the designer's viewpoint:
http://reymendoza.blogspot.com/2006/01/web-design-contract-essentials.html

And this one from the company's perspective:
http://www.out-law.com/page-521

These together should give you a handle on the problem.

3. More on the Chinese ingredient crunch…

High energy and commodity prices have plagued companies at all levels of the food industry for the past few years.

Over the past couple of years alone major players such as CP Kelco, FMC Biopolymer, BASF, Novozymes, Cargill, Danisco and DSM, have all hiked up their prices for products ranging from vitamins E and B3, to sugar molasses and citric acid.

This month DSM announced a ten per cent price increase for all its citric acid, produced in Belgium, on a worldwide basis. The increase, which is effective immediately, was "due to cost increases in raw materials and in energy".

In the wake of "sharp increases" in raw materials, in September the firm further announced a 10 per cent rise in global prices for vitamin E supplies. Orafti pushed up prices of its Beneo fibre ingredient by six per cent.

Bio Springer also said rising costs and shrinking supply of sugar molasses were driving up the cost of yeast extract production, announcing a double digit price increase for its extracts as of next year. Sugar molasses are the main raw material for yeast extracts but over the past three years the cost of sugar molasses has risen by 10 per cent. Energy prices and the impact of the EU's sugar reform were blamed.

This summer Swiss biotech company Lonza announced a worldwide price hike of up to 12 per cent for vitamin B3 in a bid to pass-on increasing production costs…

For more see:
nutraingredients.com/news/ng.asp?n=80369&m=1NIEO08&c=jegwylrviswtnqa
ap-foodtechnology.com/news/ng.asp?n=80370-us-department-of-agriculture-dean-foods-wimm-bill-dann
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4. Where are the FDA’s AER Regulations?

Industry criticizes FDA for failure to act - where are the FDA regulations?
Companies turning to private experts for guidance.

"The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration. The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

For more information on private alternatives to meet the statutory requirements: www.aer-consultants.com
-----------------------------------------------------------------5. When to patent.

This is a good background article on patenting: “Patently wise: what, how and where to patent” by Michel Morency and James Ewing

October 10, 2007 - Patent protection can be an effective tool for excluding competitors and generating revenues, if used wisely and married to a company's business strategy. Conversely, obtaining patents can quickly become an expensive and wasteful proposition if done haphazardly and not tied to an effective business strategy.

With the nutraceutical industry spending more and more resources on research and development, companies are turning to patents to protect their new products and investments. However, to get the most out of a patent, manufacturers need to familiarize themselves with the limits and potential of the process.

The first step in designing an effective patent strategy is to understand what a patent can and cannot do for the owner. A patent does permit the patent owner to exclude competitors from making, using, importing and selling the invention, as claimed in the patent.

The fact that a commercial product is described in the patent application is of no use if it is not covered by the scope of the claims. Accordingly, it is important to continuously monitor any claim amendments and any change to the product to ensure that the claims actually cover the final commercial product. A patent does not grant the patent owner the right to make, use, or sell the invention if doing so would infringe another party's patent.

Therefore, a patent strategy should always include a review of third party patents...

Finally, it is important to note that a patent can only be enforced in its country of origin… Obtaining patent protection in several countries can be a very expensive ordeal. The filing and translation costs alone can reach $10,000-15,000 per country. Costs of securing patent protection in a large number of countries can easily reach multiples of $100K or millions over the lifetime of the patents.

A common international patent strategy is to pursue patents in key developed health care markets including the US, Canada, Europe, Japan and Australia... A common misconception is that a company needs to obtain a patent in each and every country in which the product will be sold. A patent is not required to make, use, or sell in a given country; it is only useful to exclude competitors… Your patents are an important asset to your company…

Michel (Mike) Morency, Ph.D., LL.B., is a partner in Foley's Boston office… He can be contacted … via email at mmorency@foley.com - James F. Ewing, Ph.D., J.D., is senior counsel in Foley's Boston office… He can be contacted … via email at jfewing@foley.com

Good web design … sticking to a small set of guiding principles and avoiding some very common mistakes…

1. Keep Everything Obvious - Don't Make Me Think… Visitors to a website expect certain conventions, breaking these is a great way of losing visitors. People expect to find the navigation at the top of a page or on the left hand side. Logos are mostly found on the top left. Much research has been conducted into how people view and use web pages. The good news is that you do not to know all of this; instead look at how larger companies such as eBay, Amazon, Google, Microsoft structure their pages and the language they use, then emulate them.

2. Limit Colours - A website using too many colours at a time can be overwhelming to many users… Limiting a palette to 2 or 3 colours will nearly always lead to a slicker looking design…

3. Be Careful With Fonts - The set of fonts available to all visitors of a website is relatively limited… It is advisable to stick to fonts such as Arial, Verdana, Courier, Times, Geneva and Georgia… Black text on a white background is far easier for the majority of people to read than white text on a black background. If you have large amounts of text then a white or pale background is far more user friendly. Always ensure that there is a good contrast between any text and its background…

4. Plan for Change - …The ability to add or remove content from a website is fundamental… Understanding how to use Cascading Style Sheets (CSS), avoiding unconventional layouts and complicated backgrounds will all help enormously.

5. Be Consistent - Again, don't make your visitors think! About how to use your site at least. If your navigation is at the top on your homepage, it should be at the top on all other pages too. If your links are coloured red ensure the the same convention is used on all sections…

6. Keep it Relevant - A picture is better than a thousand words but if the picture you took on holiday is not relevant to your Used Car Sales website then you should really replace it … If you can take something off of your web page without it adversely affecting the message, appearance or legality of your website you should do it without hesitation… Keeping your content focused will ultimately help your search-engine rankings.

7. Become a CSS Expert - Cascading Style Sheets should be any web designer's best friend. CSS makes it is possible to separate the appearance and layout of your page from the content. This has huge benefits when it comes to updating and maintaining your site, making your site accessible and making your site easy for search engines to read…

8. Avoid Complexity - Using standard layouts for your web page will save you development time and make your site easier to use…

The principles above all border on common sense and are well known to most people, yet so many sites continue to deviate away from them and suffer as a consequence. Following these principles will help you keep away from trouble, although it still doesn't guarantee it!

About the Author: Paul has worked as a programmer and in Web Design for over 15 years. morley-computing.co.uk - entireweb.com/newsletter/archive/2007/ISSUE378.html

Your access to DHEA is in jeopardy! The Senate is considering a bill, S. 762, to classify DHEA as an anabolic steroid, adding it to the list of controlled substances and removing it from the market. H.R. 1249 is the companion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible.

DHEA is not an anabolic steroid. It is a naturally occurring hormone that has a wide range of benefits, including maintaining muscle strength and strong bones, boosting immunity, and improving mood and sleep patterns. Further
studies suggest that DHEA may be helpful for such conditions as obesity, cancer and Alzheimers disease. DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. – http://www.capwiz.com/nnfa/issues/bills/?bill=9492216 ”

We need your help to keep DHEA legal. Send a message to Congress asking your Senators and Representative to oppose S. 762 and H.R. 1249 and any amendment to restrict access to DHEA to minors. Congress should not restrict access to a dietary supplement that has given health to millions of Americans. Take action now!

If you want some background see my article on how I kept DHEA legal in 1995. http://www.lifespirit.org/dhealegal.html
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Index

3. Do you sell to Europe?

If people in Europe buy through your web site, you do. “The scope of the changes will not just affect food packaging, but any content including websites associated with the food.”

10/03/2007 - UK's Innocent has been rapped on the knuckles for making a health claim about its smoothie having a high antioxidant content and detoxifying effect. The Advertising Standards Authority (ASA) said an advert by the firm, which claimed its fruit juice contained more antioxidants than the "five-a-day" portion, was not truthful or substantiated.

The verdict will come as a blow to Innocent and could set a precedent for other companies looking to make claims about antioxidant ability of fruit. It also adds the pressure on speeding up EU rules, which will require all health claims to meet a Commission-improved list. Although no official wording or accepted health claims have been approved, it seems that advertising regulators are already tightening up on health claims in preparation, and food companies should think carefully before making a health claim.

This is the second time in a week a company has come under fire for making a statement about a products' health or nutritional benefit. Last week the UK Tea Council was criticised for exaggerating the benefits of tea, and banned from making further claims about the drinks' antioxidant potential after running a series of adverts...

Under regulation (EC) No 1924/2006, which came into force in the UK from 1 July 2007, any food product claiming to have a health benefit must meet a list of European Commission-approved wording and be supported by scientific evidence.

Although the regulation came into force this month in the UK, the European Commission is not expected to agree a list of approved literature until the end of the year. The scope of the changes will not just affect food packaging, but any content including websites associated with the food.

--------------------------------------------------------4. Vitamin Lawyer Oversight Seal"The trademark Vitamin Lawyer Oversight Seal may only be displayed on a website if the owner of the website meets or exceeds specific standards. Displaying the Seal indicates:1. The Website content has been reviewed for FDA and FTC regulation compliance by The Vitamin Lawyer.*2. The Company’s cGMP (Current Good Manufacturing Practices) have been reviewed for government and industry standards.3. The Company’s product labels are formatted and printed in conformity with FDA regulations.4. The Company’s Internet advertisements comply with FDA/FTC regulations.5. The Website’s content has been reviewed for clarity and appropriateness.Subject to the Vitamin Lawyer Consultancy standard retainer agreement.http://tinyurl.com/2cfoyb - Oversight Seal

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5. 7 Marketing Mistakes to Avoid when Promoting your Business

Entireweb Newsletter * October 2, 2007 * ISSUE #375
www.entireweb.com

Many people rush into business thinking it will be easy to run, but very soon they realize that it is not as easy as it looks. A successful business is a finely tuned machine. In order to keep your business running smoothly it is important to avoid making mistakes. Here are the 7 most common mistakes to avoid:

1. Not having clear objectives: Many business people start a business without clear objectives. They fail to set realistic goals for their marketing and consequently set themselves up for failure. It is important to make a list of goals and objectives based on a quarterly time line...

2. Neglecting to analyse your potential customers: Neglecting to analyse your potential customers is a dangerous mistake... When you do not analyse your customers wants and needs you do not know what products and services to develop for them. This will lead to targeting the wrong market and neglecting to understand your own niche market...

3. Not testing: By not testing your sales copy and places you advertise with split testing your advertising, you will be losing sales... If you do not test your ad copy and marketing promotions you will not have a proper idea of the ads and promotions that are pulling and what is not working...

4. Not budgeting: Budgeting is extremely important in business. Your business should never run out of money. This is especially true with your marketing and advertising ventures. It is important to have a monthly or quarterly budget for your marketing... Start small, test and then build on successes. This will allow you to always stay solvent and have enough for promotions.

5. Giving up too soon: Companies go out of business at an alarming rate these days. One of the reasons is that the owners give up too soon... You need to give your promotions at least 3 months before you decide to scrap them... As always, test all marketing tactics before you launch a larger promotion...

6. Poor sales copy: How often have you wanted a product but when you read the sales page you had serious doubts? Poor unprofessional ad copy will cost you sales...

7. Not screening your employees carefully...

The golden rule is to diversify. You should always use multiple forms of marketing promotions in your business. Do not just do one or two promotions and then wait for results. This will slow company growth and your business will stagnate...By avoiding these mistakes you will take your company to the success you deserve... So plan ahead and be careful not to make these common mistakes.

About the Author: Sean McPheat is a leading authority marketing consultant and helps businesses across the UK, Europe, US and the Middle East... www.seanmcpheat.com

About Me

The Vitamin Conslutancy - www.vitaminconsultancy.com -- I practiced law for 36 years in NJ (1971 - 2006), gaining a reputation as The Vitamin Lawyer, representing people in the Natural Products, Dietary Supplements and CAM (Complementary and Alternative Modalities) fields. Now I provide educational services and I consult with lawyers and other professionals, formulators, manufacturers and purveyors of natural and nutritional products, as well as with CAM enterprises and practitioners.
I started these blogs to comment on health and freedom issues and to provide an archive of information for my clients and associates. This is a private expressive association communication.
I have been a trustee of several NGOs (nongovernmental organizations) including the Natural Solutions Foundation - globalhealthfreedom.org - Institute for Health Research - inhere.org - Sound Health Research Institute - soundhealthresearch.org and LifeSpirit Church - lifespirit.org